The Recommendations for Strengthening the Investigator Site Community aim to encourage greater long-term engagement and participation by clinical site investigators.

The CTTI's report states that:‘…evidence suggests that many investigators are leaving clinical research due to difficulty balancing workload, time requirements to conduct trials, data and safety reporting burdens, and financial issues…

‘ Substantial time and resources are needed to initiate and train new site investigators in clinical trial processes …

High attrition rates for U.S.-based investigators and the resultant need to initiate new investigators to sustain an adequate pool increase the costs of performing clinical trials and threaten the quality and efficiency of trial conduct.

The recommendations focus on strengthening four key categories of site-based research activity:

1.Developing site-based research infrastructure and staff;

2.Optimizing trial execution and conduct;

3.Improving site budget and contract negotiations; and

4.Discovering additional trials to conduct.

When asked about the impact of these recommendations Dr Marisa Petersen, CEO of George Clinical said: “These recommendations are an important formal framework for the sector. George Clinical have embraced these recommendations noting that they align well with our unique integrated scientific leadership service, designed to provided peer to peer support for investigators.

“As the number of clinical trials increase in the Asia-Pacific, these clear and transparent guidelines will be a great asset and reassurance for sponsors looking to bring their compound into the world’s most dynamic market.”

The Clinical Trials Transformation Initiative (CTTI) co-founded by Duke University and the FDA is a public-private partnership whose mission is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials.

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